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Additional Sections - Amendments to the Food and Drugs Act: Guide to New Authorities

Guide to New Authorities:

Power to require assessments

Power to require test, studies, etc.

The Regulations Amending the Food and Drug Regulations (Vanessa's Law) was published in Canada Gazette, Part I on April 22, 2017 for a 75-day consultation period. The proposed Regulations would strengthen the Department's ability to regulate drugs based on a life cycle approach and support the coming into force of new powers under Vanessa's Law to require assessments, tests and studies.

In order to help applicable stakeholders comply with the proposed regulatory requirements, the following additional sections are being proposed for insertion into Health Canada's guidance document “Guide to New Authorities” on “Power to require assessment” and “Power to require tests, studies, etc.”

No other substantive changes are proposed to the “Guide to New Authorities” at this time.

Section 21.31 - Power to require assessment

21.31 Subject to the regulations, the Minister may order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product to which the authorization relates and provide the Minister with the results of the assessment.

Who can use the power?

Only the Minister of Health or the Minister's designate can exercise the power. The regulator's decision to exercise the power relies upon the scientific evaluation and recommendation of Health Canada experts.

To whom does it apply?

The Order is made to the holder of a therapeutic product authorization as specified in C.01.052 (1)(b) of the Food and Drug Regulations, specifically that must be a person who holds one or more of the following authorizations:

a drug identification number (DIN) that has been assigned under subsection C.01.014.2(1),

an establishment license (EL) that has been issued under subsection C.01A.008(1), or,

a notice of compliance (NOC) that has been issued under section C.08.004 or C.08.004.1

To what does it apply?

As specified in subsection C.01.052 (1)(a) of the regulations the order must relate to a drug. However it does not apply to natural health products.

Threshold

The Minister may order an authorization holder to conduct an assessment of the drug to which the authorization relates and provide the Minister with the results of the assessment if, as per subsection C.01.052(1)(c), the Minister has reasonable grounds to believe that:

In the case of a DIN or NOC holder the benefits or risk of injury to health associated with the drug are significantly different than they were when the authorization was issuedFootnote 1 or,

In the case of an EL holder who is an importer, the manner in which the drug is imported, or the manner in which the drug is fabricated, packaged/labelled or tested outside of Canada, may present a risk of injury to health associated with the drug, or,

In the case of an EL holder other than an importer, the manner in which the holder conducts an authorized activity may present a risk of injury to health associated with the drug.

Scope of the power

New information available to the Minister indicating that the benefits of the drug or risks of injury to health associated with it has changed since the original authorization may result in the issuance of an assessment Order. Such an Order should be used only when an authorization holder is not willing to voluntarily conduct an assessment and provide the results to the Minister. The authorization holder can only be ordered to assess existing information. The power to order a test and study under section 21.32 provides the Minister with an ability to obtain new information.

Before issuing an Order

Notification and Opportunity to Respond

Prior to issuing an Order under section 21.31, the Minister would notify the authorization holder that he or she believes that based on new information the threshold for issuing an assessment order has been reached. The Minister would not be able to order an authorization holder to conduct an assessment solely on information that had been previously provided in support of an application for market authorization or to license an establishment.

The notification will also provide the authorization holder with a reasonable opportunity to respond to the notification (e.g., to correct an error in fact, dispute the proposed exercise of the power, or voluntarily comply with the notification). The timeframe for response should be specified and reasonable in the circumstances. The timeframe may vary depending upon the severity and immediacy of risk that the product presents.

Should the holder fail to respond to the notification, the Minister may issue an Order. For further discussion of sufficient notification, see Annex B.

What would an Order look like?

An Order is instructions, decisions or directions given by the Minister which are authorized by the legislation. Orders issued by the Minister will be accompanied by reasoned decisions to allow for more transparent decision-making. Reasoned decisions should be based on evidence and should clearly communicate the decision taken and the evidence used to make the decision so that the affected party understands how the result was reached.An Order issued by the Minister to the authorization holder in accordance with section 21.31 of the Food and Drugs Act should include:

the person(s) it applies to;

the legislative provision being relied upon;

the drug and relevant authorization subject to the Order (including lot number, manufacturing site, etc.);

the rationale as to why the Minister now believes that the benefits or risks associated with the drug are different than when the authorization was issued;

the timeframe for responding to the Order and providing the Minister with the results of the assessment ; and,

the legal consequences for contravention of the Order.

In accordance with s. 21.4(2), the Order must be made publicly available.

Reasoned decisions accompanying the Order should be unbiased and include:

The legislative power being relied upon;

What the decision is;

An explanation of the basis for the decision and how it was reached, including:

a narrative and chronological review of the facts,

the scientific or other new evidence considered,

any findings on important questions of fact and the accompanying analysis, and;

any relevant criteria considered as part of the threshold determination.

What must the Minister do after examining the results of an assessment?

As per subsection C.01.052(2) of the regulations, the Minister must, after examining the results of an assessment:

provide the authorization holder with the results of the examination; and,

publish on the Government of Canada website a summary of the results of the examination along with a description of any actions that the Minister has taken or may take as a consequence of the examination.

What steps may the Minister take after examining the results of an assessment?

The Minister may, having been satisfied that the benefits or risks associated with the drug are not significantly different from when the authorization was issued may take no further action.

The Minister may however have sufficient information to warrant further regulatory action including cancelling a DIN or suspending an NOC or EL.
As per subsections C.01.014.6(3) and C.08.006(3), the Minister may cancel the assignment of a DIN or suspend an NOC if:

the authorization holder has failed to comply with the order; or

the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health.

As per section C.01A.017.1 of the regulations, the Minister may suspend an EL if:

the licensee has not complied with the order; or

the Minister determines that the results of the assessment are not sufficient to establish that the licensing requirements in C.01A.005(l), C.01A.005(m)(ii) or (iii) or C.01A.005(o) continue to be met.

Before taking this type of action, the Minister should consider whether there are other more appropriate means of mitigating the risks by providing the authorization holder an opportunity to be heard and demonstrate how these means will be implemented.

Section 21.32 - Power to require tests, studies, etc.

21.32 Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product's effects on health or safety, order the holder of a therapeutic product authorization to

compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; and

;provide the Minister with the information or the results of the tests, studies or monitoring.

Who can use the power?

Only the Minister of Health or the Minister's designate can exercise the power. The regulator's decision to exercise the power relies upon the scientific evaluation and recommendation of Health Canada experts.

To whom does it apply?

The Order is made to the holder of a therapeutic product authorization as specified in C.01.053 (b) of the Food and Drug Regulations, specifically that must be a person who holds one or more of the following authorizations:

a drug identification number (DIN) that has been assigned under subsection C.01.014.2(1),

an establishment license (EL) that has been issued under subsection C.01A.008(1), or,

a notice of compliance (NOC) that has been issued under section C.08.004 or C.08.004.1.

To what does it apply?

As specified in subsection C.01.053 (a) of the regulations the Order must relate to a drug; however it does not apply to natural health products.

Threshold

The Minister may issue an Order under Section 21.32 of the Act if, as per subsection C.01.053(c), the Minister has reasonable grounds to believe that:

In the case of a DIN or NOC holder there are significant uncertainties related to the benefits or harms associated with the drug,

In the case of an EL holder, the manner in which the holder conducts an activity has introduced significant uncertainties relating to the benefits or harms associated with the drug,

The authorization holder is currently unable to provide the Minister with information sufficient to manage those uncertainties; and

The applicable requirements in the regulations as well as any terms and conditions that have been imposed on the authorization do not allow for sufficient information to be obtained to manage those uncertainties.

Things the Minister must consider before issuing an Order.

As per subsection C.01.053(d) of the regulations, the Minister must take into account the following matters:

Whether the activities the holder will be ordered are feasible; and

Whether there are less burdensome ways of obtaining additional information about the drug's effects on health or safety.

This means that the Minister should be confident that it would be possible for the holder to conduct the activities in a timely manner without undue burden and that information produced as a result of the activities may resolve the uncertainties.

Scope of the power

Such an Order should be used only when an authorization holder is not willing to voluntarily conduct a test or study, compile information or monitor experience with respect to a drug that the Minister considers necessary to manage uncertainties associated with a drug. It is recognized that there may always be uncertainties associated with any drug and the Minister's use of this power should be reserved for those instances where a lack of knowledge could be detrimental to human health and safety.

For example, if information supporting the safety of a drug was determined to be invalid because deficiencies in the test methods used to obtain that information failed to detect harms associated with the drug.

Before issuing an Order

Notification and Opportunity to Respond

The Minister will, prior to issuing an Order under section 21.32, notify the authorization holder that he or she believes that based on new information the threshold for issuing such an order has been reached. The Minister should also provide information demonstrating his or her considerations as per subsection C.01.053(d) of the regulations.

The notification will also provide the authorization holder with a reasonable opportunity to respond to the notification (e.g., to correct an error in fact, dispute the proposed exercise of the power, or voluntarily comply with the notification). The timeframe for response should be specified and reasonable in the circumstances.

Should the holder fail to respond to the notification, the Minister may issue an Order. For further discussion of sufficient notification, see Annex B.

What would an Order look like?

An Order is instructions, decisions or directions given by the Minister which are authorized by the legislation. Orders issued by the Minister will be accompanied by reasoned decisions to allow for more transparent decision-making. Reasoned decisions should be based on evidence and should clearly communicate the decision taken and the evidence used to make the decision so that the affected party understands how the result was reached.

An Order issued by the Minister to the authorization holder in accordance with section 21.32 of the Food and Drugs Act should include:

the person(s) it applies to;

the legislative provision being relied upon;

the drug and relevant authorization subject to the Order (including any applicable details such as lot number, manufacturing site, etc.);

a description of the uncertainties and the activities ordered by the Minister intended to resolve them;

an explanation of how the Minister assessed the feasibility of the activity and whether he or she considered other less burdensome means of obtaining the information ;

the timeframe for responding to the Order and providing the Minister with the results of the activity ; and,

the legal consequences for contravention of the Order.

In accordance with s. 21.4(2), the Order must be made publicly available.

Reasoned decisions accompanying the Order should be unbiased and include:

The legislative power being relied upon;

What the decision is;

An explanation of the basis for the decision and how it was reached, including:

a narrative and chronological review of the facts,

the scientific or other new evidence considered,

any findings on important questions of fact and the accompanying analysis, and;

any relevant criteria considered as part of the threshold determination.

What steps may the Minister take after examining the results of a test, study or compiled information?

The Minister may, having been satisfied that the uncertainties have been resolved or adequately managed take no further action.

The Minister may however have sufficient information to warrant further regulatory action as appropriate that could include: a) suspending an NOC under Section C.08.006 of the Food and Drug Regulations, b) triggering the stop sale process under Section C.01.013, c) placing terms and conditions on an EL under Section C.01A.012, d) ordering a label or packaging change under Section 21.2 of the Food and Drugs Act or e) issuing an Order to recall the drug under Section 21.3.

Footnote 1

“significantly different” means that there is a strong possibility that the new information available about the drug would have influenced the Minister’s issuance of the authorization including aspects of the authorization such as the indications for use, contraindications, warnings or other means of managing the drugs harms, benefits and uncertainties.

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